[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Stelexis BioSciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100610758","phase-1-study-of-stlx-2012-in-healthy-volunteers-100610758",false,"NCT07231744","Study of STLX-2012 in Healthy Volunteers","A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of STLX-2012 in Healthy Volunteers","Inclusion Criteria:\n\n* Male or female participants aged 18-55 years old, inclusive, at Screening.\n* Body mass index of 18-32 kg\u002Fm\\^2, inclusive\n* Healthy as determined by the investigator\n* Adequate hepatic and renal function\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n* Male participants and females of childbearing potential must agree to use an effective method of contraception for 30 days after the last dose of STLX-2012\n\nExclusion Criteria:\n\n* Pregnant or lactating female.\n* Positive urine drug screen or alcohol breath test\n* Neutropenia, defined as neutrophil count \\\u003C2.0 x 10\\^9\u002FL\n* History of allergic reaction requiring treatment or anaphylactic reactions to any therapeutic drug.\n* Previous treatment with an IL-1RAP monoclonal antibody\n* History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, inflammatory, or allergic disease (excluding mild seasonal allergies)",true,"ALL","18 Years","55 Years",{"count":21,"type":22},32,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this research is to establish the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single IV dose of STLX-2012.",[28],"Healthy Participants","NOT_YET_RECRUITING","2026-04-21",{"date":32,"type":33},"2026-04-22","ACTUAL",{"date":35,"type":22},"2026-10",{"date":37,"type":22},"2027-02",{"name":39,"class":40},"Stelexis BioSciences","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100557103","phase-1-eganelisib-as-monotherapy-and-in-combination-with-cytarabine-in-relapsedrefractory-aml-100557103","NCT06533761","Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed\u002FRefractory AML","A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination With Cytarabine in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary AML and treatment-related AML can be included); Higher-risk (IPSS-R Intermediate, High or Very High Risk at time of study entry) myelodysplastic syndromes (HR-MDS) according to WHO 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n* Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib.\n\nExclusion Criteria:\n\n* Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1.\n* Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency).\n* Active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for \\>72 hours prior to treatment\n* WBC count \\>25 × 10\\^9\u002FL measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count).\n* Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.",{"count":50,"type":22},125,[25],"This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed\u002Frefractory (r\u002Fr) acute myeloid leukemia (AML) or r\u002Fr higher-risk myelodysplastic syndromes (HR-MDS).\n\nThe study consists of 2 parts:\n\n* Part 1: Dose Escalation (DE) in both monotherapy and in combination.\n* Part 2: Dose Optimization",[54,55],"AML, Adult","MDS","RECRUITING","2025-10-20",{"date":59,"type":33},"2025-10-22",{"date":61,"type":33},"2025-04-28",{"date":63,"type":22},"2028-03-15",{"name":39,"class":40},13,""]